Phase 3 Extension Study of the Safety and Efficacy of Aldurazyme® (Laronidase) in Mucopolysaccharidosis I (MPS I) Patients

Completed · Phase 3 · Has a placebo group

Conditions studied: Mucopolysaccharidosis I, Hurler's Syndrome, Hurler-Scheie Syndrome, Scheie Syndrome

In brief

This study is being conducted to collect additional long-term efficacy and safety data of Aldurazyme® (laronidase) patients with MPS I disease. Patients who were previously enrolled in the Phase 3 Double-Blind Study will be enrolled in this study.

Key facts

Study ID

NCT00146770

Run by

Genzyme, a Sanofi Company

People needed

45

Starts

2001-05-01

Expected to finish

2005-03-01

Last updated by the study team

2015-04-03

Who can join

Age: any. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• The patient or patient's legal guardian must provide written informed consent prior to any protocol-related procedures being performed.
• The patient must have successfully completed Study ALID-003-99 (who received 21 of 26 consecutive weekly infusions).
• The patient has not experienced any safety issues that would contraindicate participation in the Extension study.
• A female patient of childbearing potential must have a negative pregnancy test at entry

You may not qualify if…

• The patient is pregnant or lactating.
• The patient has received an investigational drug within 30 days prior to the study enrollment.
• The patient has a medical condition, serious intercurrent illness, or other extenuating circumstance that may significantly interfere with study compliance including all prescribed evaluations and follow-up activities

Where it is running

• University of South Alabama — Mobile, Alabama, United States
• Emory University School of Medicine — Atlanta, Georgia, United States
• University of Rochester — Rochester, New York, United States
• University of North Carolina at Chapel Hill — Chapel Hill, North Carolina, United States
• Toledo Children's Hospital — Toledo, Ohio, United States
• Merle West Medical Center — Klamath Falls, Oregon, United States
• The Childrens Hospital of Philadelphia — Philadelphia, Pennsylvania, United States
• Rhode Island Hospital — Providence, Rhode Island, United States
• Hospital Universatario de Universidade Federal de Santa Catarina — Florianópolis, Brazil
• Hospital Infantil Joana de Gusmao — Florianópolis, Brazil
• The Hospital for Sick Children — Toronto, Ontario, Canada
• Alberta Children's Hospital — Calgary, Canada
• Children's Hospital Klinikum Nord Heidberg — Hamburg, Germany
• Medizinishe Hochshule Hannover — Hanover, Germany
• Children's Hospital at the University Hospital of Heidelberg — Heidelberg, Germany
• Children's Hospital Klinikum der F.S. Universitat — Jena, Germany
• Catholic University Sacro Cuore — Rome, Italy
• Academisch Ziekenhuis Rotterdam — Rotterdam, Netherlands
• Blackpool Victoria Hospital — Blackpool, Lancashire, United Kingdom
• Belfast City Hospital — Belfast, United Kingdom
• Birmingham Children's Hospital — Birmingham, United Kingdom
• Bristol Royal Hospital for Children and Frenchay Hospital — Bristol, United Kingdom
• Gartnavel Hospital — Glasgow, United Kingdom
• Great Ormond Street Hospital for Sick Children and NHS Trust — London, United Kingdom
• Royal Victoria Hospital — Newcastle upon Tyne, United Kingdom

Full record on ClinicalTrials.gov

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